A Randomized Clinical Trial On Management Of Early Pregn

背景：米索前列醇用于早期妊娠失败的药物治疗越来越多。然而，这种治疗的有效性，安全性和可接受性尚未在大型随机试验中确定。 研究方法：这项多中心试验将652名早期妊娠失败（无胚妊娠、胎儿死亡、不完全和不可避免的自然流产）的妇女随机分为两组，一组接受真空抽吸（VA，标准护理），另一组接受800 μ g阴道米索前列醇，比例为1：3。接受米索前列醇的受试者在第3天返回。如果POC排出不完全，则给予第二剂800 ig阴道米索前列醇。第8天，如果排出仍不完全，则提供VA。第15天，所有受试者返回接受随访访视。在第30天进行电话采访。失败定义为在初始治疗后30天内因任何原因VA（对于米索前列醇治疗组）或再灌注（对于VA组）。该研究旨在检验米索前列醇组的成功率是否比VA组低18%。如果两组之间的成功率差异不超过18%，则认为治疗等同。 结果：总体而言，分别有491名和161名妇女被随机分为内科或外科治疗组。两组的基线特征具有可比性。在米索前列醇组中，71%的妇女在第3天完全排出，85%在第8天完全排出。总体而言，VA组3%和米索前列醇组15%发生治疗失败（差异= 12%，90% CI 9，16%）。需要住院治疗的出血或腹膜炎很少见（<1%），两组之间没有差异。接受内科和外科治疗的女性中，治疗后急诊就诊的比例分别为3.1%和2.0%（p = 0.59）。78%的女性会再次选择米索前列醇，83%的女性会在需要时推荐给其他人。可接受性与VA组无差异。 结论：米索前列醇800 mg阴道给药治疗早期妊娠失败安全有效，成功率85%左右。出血和腹膜炎的风险很低，副作用可以耐受。这是大多数参与者可以接受的治疗。

Background: Medical management with misoprostol for early pregnancy failure has been increasingly used. However, the efficacy, safety and acceptability of this treatment have yet to be established in a large randomized trial. Methods: This multicenter trial randomized 652 women with a first trimester pregnancy failure (anembryonic gestation, fetal demise, incomplete and inevitable spontaneous abortion) to receive either vacuum aspiration (VA, standard of care) or 800 ig vaginal misoprostol in a 1:3 ratio. Subjects receiving misoprostol returned on Day 3. If the expulsion of POC was incomplete, a second dose of 800 ig vaginal misoprostol was given. On Day 8, if the expulsion was still incomplete, VA was offered. On Day 15, all subjects returned for follow-up visit. A telephone interview was conducted on Day 30. Failure was defined as VA (for the misoprostol treatment group) or reaspiration (for the VA group) for any reason within 30 days after the initial treatment. The study was powered to test whether the success rate in the misoprostol group was lower than that in the VA group by 18%. If the difference in success rate between the two groups did not exceed 18%, the treatments would be considered equivalent. Results: Overall, 491 and 161 women, respectively, were randomized to medical or surgical management. Baseline characteristics of the two groups were comparable. In the misoprostol group, 71% of women had complete expulsion by day 3 and 85% by day 8. Overall, treatment failures occurred in 3% of the VA group and 15% of the misoprostol group (difference = 12%, 90% CI 9, 16%). Hemorrhage or endometritis that required hospitalization was rare (< 1%) and there were no differences between the two groups. Emergency hospital visit after the treatment occurred to 3.1% and 2.0% of women who received medical and surgical treatment, respectively (p = 0.59). 78% of women would choose misoprostol again and 83% recommend to others if needed. The acceptability was not different from that in the VA group. Conclusion: Treatment of early pregnancy failure with 800 mg misoprostol per vagina is efficacious and safe with a success rate of around 85%. The risks for hemorrhage and endometritis are very low, and the side-effects are tolerable. It is an acceptable treatment to the majority of the participants.